A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus
A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled, and Open-label Comparator Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus
2 other identifiers
interventional
248
8 countries
83
Brief Summary
A Phase 2b, study to measure the effect of Cotadutide at different doses versus placebo or comparator (semaglutide) in participants who have Chronic Kidney Disease with Type 2 Diabetes Mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started Aug 2020
Typical duration for phase_2 type-2-diabetes-mellitus
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2020
CompletedFirst Posted
Study publicly available on registry
August 17, 2020
CompletedStudy Start
First participant enrolled
August 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2022
CompletedResults Posted
Study results publicly available
January 17, 2025
CompletedJanuary 17, 2025
December 1, 2024
1.5 years
July 6, 2020
March 4, 2023
December 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Primary Endpoint Was Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks
Percentage change in UACR of cotadutide at different dose levels compared to placebo after 14 weeks. Efficacy endpoints for cotadutide vs. semaglutide are exploratory and are therefore excluded.
Baseline to the end of 14 weeks of dosing
Secondary Outcomes (11)
Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 26 Weeks
Baseline to end of 26 weeks of dosing
Percent Change in Body Weight of Cotatudide at Different Dose Levels Versus Placebo From Baseline to End of 14 Weeks of Dosing
Baseline to end of 14 weeks of dosing
Percentage Change in Body Weight of Cotadutide at Different Dose Levels Versus Placebo From Baseline to End of 26 Weeks of Dosing
Baseline to end of 26 weeks of dosing
Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 14 of Dosing
Baseline to end of 14 weeks of dosing
Percent Change in HbA1c of Cotadutide at Different Dose Levels Versus Placebo From Baseline to the End of 26 of Dosing
Baseline to end of 26 weeks of dosing
- +6 more secondary outcomes
Study Arms (5)
Cotadutide 100 micrograms
EXPERIMENTALCotadutide 100 micrograms administered subcutaneously
Cotadutide 300 micrograms
EXPERIMENTALCotadutide 300 micrograms administered subcutaneously
Cotadutide 600 micrograms
EXPERIMENTALCotadutide 600 micrograms administered subcutaneously
Placebo
PLACEBO COMPARATORPlacebo administered subcutaneously
Semaglutide
ACTIVE COMPARATORSemaglutide 1.0 miligrams administered subcutaneously
Interventions
Cotadutide 100 micrograms administered subcutaneously
Cotadutide 300 micrograms administered subcutaneously
Cotadutide 600 micrograms administered subcutaneously
Semaglutide 1.0 miligrams administered subcutaneously
Eligibility Criteria
You may qualify if:
- Estimated glomerular filtration rate ≥ 20 to \< 90 mL/min/1.73 m2 determined at the screening visit or a documented occurrence in medical history at least 3 months prior to randomisation.
- Receiving background standard of care treatment for renal disease and/or T2DM and being treated according to locally recognised guidelines, as appropriate.
- Receiving optimised and stable treatment with an angiotensin-converting-enzyme (ACE) inhibitor or an angiotensin II receptor antagonist for ≥ 3 months at screening at the maximum tolerated dose (MTD) unless contraindicated, not tolerated, or in the opinion of the investigator, not practically available or suitable.
- Micro- or macroalbuminuria as defined by UACR \> 50 mg/g or 5.7 mg/mmol.
- Diagnosed with T2DM with glucose control managed with any insulin and/or any oral therapy combination including metformin, SGLT2 inhibitor, thiazolidinedione, or acarbose where no major dose changes (eg, \> 50% increase in dose) have occurred within the 4 weeks prior to the start of the run-in period. Participants taking sulfonylureas or glitinides may be randomised following a 4-week washout period of the sulfonylurea/glitinide.
- Haemoglobin A1c range of 6.5 % to 12.5% (inclusive) at screening
- Body mass index \> 25 kg/m2 at screening or \> 23 kg/m2 for participants enrolled in Japan
You may not qualify if:
- History or presence of significant medical or psychological conditions, including significant abnormalities in laboratory parameters or vital signs including ECG, which in the opinion of the investigator, would compromise the participant's safety or successful participation in the study.
- Receiving renal replacement therapy or expected to require it within 6 months of being randomised
- Renal transplant or on the waiting list for renal transplantation
- Received a GLP-1 analogue-containing preparation within the last 30 days or 5 half-lives of the drug, if known (whichever is longer), at the time of Visit 2
- Received any of the following medications within the specified time frame prior to the start of the study (Visit 2):
- Aspirin (acetylsalicylic acid) at a dose greater than 150 mg once daily and within the last 3 days prior to the start of the run-in period (Visit 2)
- Paracetamol (acetaminophen) or paracetamol-containing preparations at a total daily dose of greater than 3000 mg and within the last 3 days prior to the start of the run-in period (Visit 2)
- Ascorbic acid (vitamin C) supplements at a total daily dose of greater than 1000 mg and within the last 3 days prior to the start of the run-in period (Visit 2)
- Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives of the drug, if known (whichever is longer)
- Participants with a known severe allergy/hypersensitivity to any of the proposed study interventions or excipients of the product
- Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss) or recent episodes of severe hypoglycaemia
- Type 1 diabetes mellitus (T1DM), history of diabetic ketoacidosis, or clinical suspicion of T1DM
- Participants with recent acute or subacute renal function deterioration
- Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the upper gastrointestinal tract (including weight-reducing surgery and procedures) which may affect gastric emptying or could affect the interpretation of safety and tolerability data
- History of acute or chronic pancreatitis
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (83)
Research Site
Box Hill, 3128, Australia
Research Site
Elizabeth Vale, 5112, Australia
Research Site
Fitzroy, 3065, Australia
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Heidelberg, 3084, Australia
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Melbourne, 3004, Australia
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Merewether, 2291, Australia
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Oaklands Park, 5046, Australia
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Wollongong, 2500, Australia
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Woolloongabba, 4102, Australia
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Vancouver, British Columbia, V5Y 3W2, Canada
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Barrie, Ontario, L4N 7L3, Canada
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Brampton, Ontario, L6S 0C6, Canada
Research Site
Concord, Ontario, L4K 4M2, Canada
Research Site
Etobicoke, Ontario, M9R 4E1, Canada
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Oakville, Ontario, L6M 1M1, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Ottawa, Ontario, K2J 0V2, Canada
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Toronto, Ontario, M4G 3E8, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Waterloo, Ontario, N2T 0C1, Canada
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Laval, Quebec, H7T 2P5, Canada
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Montreal, Quebec, H4A 2C6, Canada
Research Site
Berlin, 10409, Germany
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Berlin, 10437, Germany
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Berlin, 10789, Germany
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Dortmund, 44137, Germany
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Düsseldorf, 40210, Germany
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Essen, 45359, Germany
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Kassel, 34121, Germany
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Ludwigshafen, 67059, Germany
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Magdeburg, 39120, Germany
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Mainz, 55116, Germany
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München, 81241, Germany
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Münster, 48145, Germany
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Münster, 48153, Germany
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Riesa, 01587, Germany
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Sankt Ingbert, 66386, Germany
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Arakawa-ku, 116-0012, Japan
Research Site
Chitose-shi, 066-0032, Japan
Research Site
Fujisawa-shi, 251-0041, Japan
Research Site
Kamakura-shi, 247-8533, Japan
Research Site
Obihiro-shi, 080-0848, Japan
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Sapporo, 060-0062, Japan
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Shinjyuku-ku, 160-0022, Japan
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Auckland, 2025, New Zealand
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Auckland, ?0620, New Zealand
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Christchurch, 8011, New Zealand
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Grafton, 1010, New Zealand
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Havelock North, 4130, New Zealand
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New Plymouth, 4310, New Zealand
Research Site
Tauranga, 3110, New Zealand
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Wellington, 6021, New Zealand
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Bialystok, 15-435, Poland
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Grodzisk Mazowiecki, 05-825, Poland
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Katowice, 40-081, Poland
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Krakow, 30-033, Poland
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Krakow, 31-261, Poland
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Krakow, 31-530, Poland
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Lublin, 20064, Poland
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Poznan, 61-655, Poland
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Skierniewice, 96-100, Poland
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Warsaw, 00-660, Poland
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Warsaw, 01-518, Poland
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Warsaw, 02-507, Poland
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Wierzchosławice, 33-122, Poland
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A Coruña, 15006, Spain
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Barcelona, 08036, Spain
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Córdoba, 14004, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Lleida, 25198, Spain
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Madrid, 28006, Spain
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Majadahonda, 28222, Spain
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Málaga, 29010, Spain
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Palma, 07198, Spain
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Palma de Mallorca, 07010, Spain
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Pozuelo de Alarcón, 28223, Spain
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Seville, 41003, Spain
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Seville, 41009, Spain
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Valencia, 46009, Spain
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Vitoria-Gasteiz, 01009, Spain
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Dundee, DD1 9SY, United Kingdom
Research Site
Liverpool, L9 7AL, United Kingdom
Research Site
London, SE5 9RS, United Kingdom
Related Publications (3)
Selvarajah V, Robertson D, Hansen L, Jermutus L, Smith K, Coggi A, Sanchez J, Chang YT, Yu H, Parkinson J, Khan A, Chung HS, Hess S, Dumas R, Duck T, Jolly S, Elliott TG, Baker J, Lecube A, Derwahl KM, Scott R, Morales C, Peters C, Goldenberg R, Parker VER, Heerspink HJL; study investigators. A randomized phase 2b trial examined the effects of the glucagon-like peptide-1 and glucagon receptor agonist cotadutide on kidney outcomes in patients with diabetic kidney disease. Kidney Int. 2024 Dec;106(6):1170-1180. doi: 10.1016/j.kint.2024.08.023. Epub 2024 Aug 31.
PMID: 39218393RESULTYu H, Parker V, Selvarajah V, Hansen L, Robertson D, Hamren B, Khan A, Parkinson J. Pharmacokinetic-pharmacodynamic (PK/PD) modelling of cotadutide effect in patients with chronic kidney disease and type 2 diabetes mellitus. Br J Clin Pharmacol. 2025 Sep;91(9):2672-2683. doi: 10.1002/bcp.70093. Epub 2025 May 9.
PMID: 40344607DERIVEDNatale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
PMID: 39963952DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2020
First Posted
August 17, 2020
Study Start
August 31, 2020
Primary Completion
March 8, 2022
Study Completion
March 8, 2022
Last Updated
January 17, 2025
Results First Posted
January 17, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.